Australia Flags Counterfeit Rabies Vaccine in India; Manufacturer Responds | Quick Digest

Australia Flags Counterfeit Rabies Vaccine in India; Manufacturer Responds | Quick Digest
Australia issued a health advisory regarding counterfeit rabies vaccines (Abhayrab) in India since November 2023. The manufacturer, Indian Immunologicals Ltd (IIL), acknowledged a single counterfeit batch (KA24014) identified in January 2025, claiming it's no longer in circulation and deeming the advisory 'over-cautionary'.

Australia's ATAGI warned travelers about counterfeit Abhayrab vaccine in India.

Counterfeit batches circulated in India since November 2023, per Australian advisory.

Indian Immunologicals Ltd (IIL) confirmed one counterfeit batch (KA24014).

IIL stated the identified counterfeit batch was removed from circulation in January 2025.

Australian advisory recommends replacement doses for those vaccinated with Abhayrab in India.

IIL called Australia's advisory 'over-cautionary and misplaced'.

Australia's Technical Advisory Group on Immunisation (ATAGI) issued a significant health advisory warning travelers about counterfeit batches of the human rabies vaccine Abhayrab circulating in India since November 1, 2023. This alert, which has been corroborated by various news outlets, cautions that individuals who received this fake vaccine might not be adequately protected against rabies, a nearly 100% fatal disease once symptoms manifest. ATAGI recommended that anyone vaccinated in India with Abhayrab or an unknown rabies vaccine brand from the specified date onwards should consult a healthcare provider and consider receiving replacement doses with a vaccine registered in Australia, such as Rabipur or Verorab. In response, Indian Immunologicals Ltd (IIL), the Hyderabad-based manufacturer of Abhayrab, dismissed the Australian advisory as "over-cautionary and misplaced." IIL clarified that it proactively identified a packaging anomaly in one specific counterfeit batch (Batch # KA24014, manufactured March 2024, expiry February 2027) in January 2025. The company stated that it immediately notified Indian regulatory and law enforcement agencies, lodged a formal complaint, and ensured the counterfeit batch was removed from circulation. IIL further assured the public that all genuine vaccine batches undergo rigorous testing and are cleared by the Central Drugs Laboratory. This incident has also prompted similar warnings or reviews from health authorities in the US (CDC) and the UK. The concern is heightened given India's high burden of rabies, with an estimated 18,000 to 20,000 annual deaths, emphasizing the critical importance of vaccine integrity.
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